| CTRI Number |
CTRI/2018/11/016359 [Registered on: 15/11/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of the effectiveness of olanzapine, metoclopramide and domperidone for controlling chemotherapy related nausea and vomiting |
|
Scientific Title of Study
|
Comparison of the efficacy of olanzapine, metoclopramide and domperidone
for the symptom abolishment of chemotherapy induced breakthrough nausea and
vomiting, randomized open label clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhanu Prakash Bandlamudi |
| Designation |
Senior resident DM |
| Affiliation |
Jawaharlal institute of medical education and research |
| Address |
Medical oncology, regional cancer centre,jipmer, pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7760356346 |
| Fax |
|
| Email |
bhanu691@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Kayal |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal institute of medical education and research |
| Address |
Medical oncology, regional cancer centre,jipmer, pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7598118439 |
| Fax |
|
| Email |
kayalsmita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhanu Prakash Bandlamudi |
| Designation |
Senior resident DM |
| Affiliation |
Jawaharlal institute of medical education and research |
| Address |
Medical oncology, regional cancer centre,jipmer, pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7760356346 |
| Fax |
|
| Email |
bhanu691@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute Of Postgraduate Medical Education and Research,Intramural research committee |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute Of Postgraduate Medical Education and Research |
| Address |
JIPMER,
Dhanvantri Nagar,
Gorimedu,
Puducherry-605 006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bhanu Prakash Bandlamudi |
Jawaharlal institute of post graduate medical education and research |
Room no 13,medical oncology department, regional cancer centre
Pondicherry
PONDICHERRY |
7760356346
bhanu691@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee(human studies), JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tablet domperidone |
10 mg per oral three times a day for 3 days,for use in chemotherapy induced nausea and vomiting |
| Intervention |
Tablet Metoclopramide |
10 mg per oral three times a day for 3 days, For use in chemotherapy induced nausea and vomiting |
| Comparator Agent |
Tablet olanzapine |
10 mg per oral once a day for 3 days, approved for chemotherapy induced nausea and vomting |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Histologically or cytologically confirmed malignant disease
2.Chemotherapy naïve patients
3.Scheduled to receive intravenous either single or multiday highly emetogenetic chemotherapy regimens or moderately emetogenic chemotherapy regimens |
|
| ExclusionCriteria |
| Details |
1.Patients with nausea in 24 h prior to beginning of chemotherapy
2.serum creatinine of >2.0 mg/dl, serum bilirubin of >2.0 mg/dl, SGOT or SGPT values of >3 times the upper limits of normal
3.Pregnant patients
4.Patients on chemotherapy for leukemia.
5.Esophageal and stomach malignancies are excluded from the study.
6.Patients on continuous, intermittent or concomitant oral chemotherapy
7.Patients on continuous, intermittent or concomitant oral chemotherapy or on opioid (morphine) treatment for pain control.
8.Patients with known hypersensitivity to olanzapine, metoclopramide or domperidone,
9.Patients with cardiac arrhythmia, history of congestive heart failure, or acute myocardial infarction within the previous 6 months.
10.Patients with known history of CNS disease (e.g., brain metastases, seizure disorder), or treatment with any antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for 30 days prior to or during protocol therapy.
11.Patients with concurrent abdominal radiotherapy
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the efficacy of metoclopramide, olanzapine, domperidone in symptom abolishment of chemotherapy induced breakthrough nausea and vomiting |
over 1 year of DM course |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the side effect profile of metoclopramide, olanzapine, domperidone in the treatment of breakthrough vomiting |
over 1 year of DM course |
| To assess and compare QOL before and after onset of breakthrough CINV and use of study medications |
over 1 year of DM course |
| To assess the use of second line rescue for treatment of breakthrough emesis |
over 1 year of DM course |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/04/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial is being conducted to identify the appropriate drug for chemotherapy induced breakthrough nausea and vomiting. Such trials comparing multiple drugs for controlling breakthrough nausea vomiting have not been done in Indian subcontinent. Presently there is no standard drug for break through emesis in both highly and moderately emetogenic chemotherapy induced breakthrough nausea and vomiting. |